HFpEF Phenotyping With Echo, Clinical, and Biomarkers

NCT07642921 | Not Yet Recruiting

• 1 other identifier: CET N° 5131/26
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The EPIC-HFpEF registry is a nationwide Italian study that follows people with a specific type of heart failure called HFpEF. About 500 patients will be enrolled from several specialized hospitals and monitored for up to two years, without changing their usual treatment. The goal is to better understand this complex condition by identifying different patient "types" based on clinical features, heart imaging, and blood markers. Researchers will also look at how these groups are treated in real life and how their disease progresses over time. By doing this, the study aims to improve how doctors classify and manage HFpEF, moving toward more personalized and effective care for patients in the future.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Phenotyping; Heart Failure; Ejection Fraction; Obesity; Diabetes; Chronic Kidney Disease; HFpEF

Outcome Measures

Primary Outcomes (1)

• Prevalence of HFpEF phenotypes

  to evaluate the prevalence of distinct phenotypic subgroups of HFpEF agnostically classified (unsupervised) using detailed standard and advanced echocardiography (at rest and/or during exercise), clinical evaluation, biomarker characteristics, and comorbidities assessment

  At Baseline

Secondary Outcomes (3)

• Prevalence of treatment patterns according to different phenotypes

  1 year, year 1

• Correlations between biomarkers and structural and functional alterations of the heart

  At baseline

• Rate of major cardiovascular events

  3 years, year 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of consecutive patients with HF (NYHA class II - IV), aged 18 years or older, able to give their written informed consent to participate to the registry. Each patient will be uniquely identified in the study by a combination of his/her site number and patient number. No name will be entered in the database. Once obtained approval from each Ethics Committee center, consecutive patients will be included, up to the achievement of the study size. Patients may also be enrolled retrospectively, provided they give their written informed consent during a follow-up visit. Enrollment will be performed during outpatient visits or at-discharge in patients hospitalized for HF. Outpatient's visits will be further classified as planned or unplanned visits for worsening HF symptoms. Patient data collected during the study will include demographics, medical history, vital signs, LVEF and main cardiac structure and function parameters, and laboratory assessments.

You may qualify if:

• Patients ≥ 18 years old
• Signed patient informed consent form (ICF)
• Diagnosis of chronic (documented HF hospitalization in the last year) or acute decompensated HF shown by signs and symptoms of HF and LVEF \>50% and, according to guidelines and the universal definition of HF, elevated levels of natriuretic peptides (NT-proBNP ≥300 pg/ml in sinus rhythm or NTproBNP ≥600 pg/ml in atrial fibrillation), at the time of enrolment (10)
• Echocardiographic evidence of increased estimated LV filling pressures according to current guidelines

You may not qualify if:

• Planned participation or participation in a clinical trial;
• Life expectancy \< 1 year because of non-cardiac causes;
• History of recent (6 months) infective, or inflammatory, autoimmune or neoplastic diseases.
• Stage \>4 CKD (estimated glomerular filtration rate \[eGFR\] \< 15 ml/min/1.73m2),
• Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischemia or newly developed ischemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA in past 3 months;
• Chronic pulmonary disease requiring home oxygen, oral steroid therapy or hospitalization for exacerbation within 12 months;
• Congenital heart disease.
• Primary pulmonary hypertension
• Moderate-to-severe degenerative (primary) valve disease
• Cardiomyopathy based on muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), or known pericardial constriction;
• Implantation of cardioverter defibrillator (ICD) within 3 months
• Implanted cardiac resynchronization therapy (CRT) and/or stable RV pacing.

Sponsors & Collaborators

• University Of Perugia: lead
• Azienda Ospedaliera di Perugia: collaborator
• Ospedale Le Scotte: collaborator
• University of Foggia: collaborator

Related Publications (5)

• Patel HC, Hayward C, Dungu JN, Papadopoulou S, Saidmeerasah A, Ray R, Di Mario C, Shanmugam N, Cowie MR, Anderson LJ. Assessing the Eligibility Criteria in Phase III Randomized Controlled Trials of Drug Therapy in Heart Failure With Preserved Ejection Fraction: The Critical Play-Off Between a "Pure" Patient Phenotype and the Generalizability of Trial Findings. J Card Fail. 2017 Jul;23(7):517-524. doi: 10.1016/j.cardfail.2017.04.006. Epub 2017 Apr 18.

  PMID: 28434933 BACKGROUND

• Redfield MM, Borlaug BA. Heart Failure With Preserved Ejection Fraction: A Review. JAMA. 2023 Mar 14;329(10):827-838. doi: 10.1001/jama.2023.2020.

  PMID: 36917048 BACKGROUND

• Kittleson MM, Panjrath GS, Amancherla K, Davis LL, Deswal A, Dixon DL, Januzzi JL Jr, Yancy CW. 2023 ACC Expert Consensus Decision Pathway on Management of Heart Failure With Preserved Ejection Fraction: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2023 May 9;81(18):1835-1878. doi: 10.1016/j.jacc.2023.03.393. Epub 2023 Apr 19. No abstract available.

  PMID: 37137593 BACKGROUND

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

  PMID: 35363499 BACKGROUND

• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.

  PMID: 37622666 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Obesity; Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Erberto Carluccio, MD

  Cardiology and Cardiovascular Pathophysiology Unit, University of Perugia and Azienda Ospedaliera di Perugia, Italy

  STUDY CHAIR

• Alberto Palazzuoli, MD

  Cardio Thoracic and Vascular Department, Cardiovascular Diseases Unit, Le Scotte Hospital, Siena, Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: June 11, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share